Job Details

Job Summary:

The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions.

Requirements:

Role: Senior/Medical Director (ref 2004-1123-MD)

Location: London

Description:
This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences senior leadership decision-making for the projects by setting strategic direction.

Qualifications:
• Medical Degree with full GMC registration.
• 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
• Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
• NDA/MAA/Submission experience preferred.
• Management experience

Responsibilities:
Clinical Development team participation and leadership
o Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product. May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy.
o Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
o Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and commercial viability of a product.

Synopsis / Protocol Development, Study Execution, & Study Interpretation
o Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall compound strategy.
o Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.

Trial Medical Monitoring
o Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.
o Makes final decisions regarding study conduct related to scientific integrity.

External Interactions
o Directs activities involved in interactions with regulatory authories / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives.

Due Diligence, Business Development and Alliance Projects
o Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams.
o Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve strategic goals while striving to maintain good working relationship between the company and partner.

Leadership, Task Force Participation, Upper Management Accountability
o Interacts directly with research division based on pertinent clinical and development expertise and to provide knowledge / understanding of market environment in line with status as scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions. Lead the companies internal teams and may lead global cross-functional teams, as appropriate.
o Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.

Benefits:
Remuneration on request.

About us:
Synapse Medical Resourcing Ltd are dedicated to finding companies talented medical doctors, at every level. Founded by a practising pharmaceutical physician Synapse has excellent contacts with medical organisations and medical networks. This enables us to provide physicians with information about current opportunities within the pharmaceutical industry, and find the best candidate for the role.

Synapse are the only specialist recruitment company run by an industry medic and have built good working relationships with pharmaceutical companies, and physicians, providing an excellent service for both.By taking the time to get to know and understand our clients needs, we find the most suitable partnerships, creating a successful and long working relationship.

For more information about this role and, other positions that we have available please visit our website www.synapsemr.com or call us on 0207 692 0555.

To apply for this position use the ‘click here to apply’ button below or email your CV to info@synapsemr.com

Keywords: Pharmaceutical Physician, Clinical Research, Clinical Research Physician, Medical, Clinical, Research, Physician, Medical Director, GI, Gastroenterology, Senior Medical Director, Clinical Development.